Zytiga‘s official “on label” use is after chemotherapy fails. In an earlier post I referenced some clinical trial results from June that indicated great promise for use of the drug before chemotherapy. Johnson & Johnson, who makes the drug, is now seeking formal approval from the FDA for Zytiga’s use before chemotherapy. The FDA sees enough merit in earlier use of the drug that it’s fast tracking the approval process. That does not mean it will necessarily be approved for earlier use.

As I understand it, a doctor can prescribe it now for use before chemotherapy, but that’s considered an “off label” use. I suspect some doctors will not prescribe it for early use until FDA approval is granted (assuming approval is granted). If early use of the drug is of interest to you, be sure to discuss the current lack of approval in detail with your oncologist. Note the Zytiga is horribly expensive, $5,000 per month at this writing. Your insurance company may balk at covering it before FDA approval. Your oncologist may be able to convince them otherwise – it’s worth a try if you’re interested in this route.

FWIW I’m not yet at the point where Zytiga would be prescribed, the casodex is still working. If casodex were to fail before the earlier use of Zytiga is approved, though, I would want early “off label” use. That’s just for me – I am not suggesting it’s right for anyone else. Metastatic prostate cancer is complex and manifests itself in a variety of ways. Work closely with your medical team to make a decision that’s right for you and your case.